Complete Stem Cell Production in a Regulated Environment Curriculum Modules here.
Access the full workshop agenda here.
Rapid advances in stem cell and organ regeneration have put the biomanufacturing industry in a position of eminent uses. Stem cells therapies such as the treatment of macular degeneration are already in use and many more potential applications are currently in clinical trials at all phases. Lab grown organs, such as bladders, have been implanted in humans and advances in regeneration of other organ types are in development and animal trials today. The expansion of these products into human use has led to the need for training and skills in the application of stem cell technologies in an FDA regulated, current good manufacturing practice (cGMP) environment.
This workshop will introduce participants to the theory, concepts and practices of stem cell and organ regeneration in a cGMP environment. Workshop participants will conduct clean room gowning and advanced hands-on activities including the maintenance, transfer and differentiation of stem cells, and analytical methods to determine the success of directed differentiation. Additionally, guest lectures from industry experts and a tour of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, NC will be included. Following the workshop, participants will be able to:
1. Discuss aspects of stem cell maintenance and organ regeneration currently in use.
2. Describe the role played of various chemicals in directed differentiation of stem cells.
3. Explain why cGMP and clean room techniques are required for clinical trial and human use.
4. Describe the levels of clean room classification.
5. Properly gown for entry into a cGMP regulated environment.
6. Aseptically feed, transfer and treat stem cells for differentiation.
7. Perform assay(s) to determine successful differentiation; discuss other methods not used in this workshop.
Describe a research and cGMP facility actively engaged in stem cell / regenerative medicine science.
At the conclusion of the mini-BIOMAN, participants will have a comprehensive, ready-to-insert curriculum module to utilize in their own classrooms. Curricular materials include standard operating protocols (SOPs), PowerPoint slides and links to helpful resources and references. Breakfast and lunch will be provided each day of the conference, and transportation to off-site venues is included. Hotel accommodations and travel funds are available for out-of-town participants.